Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
1062 participants
INTERVENTIONAL
2006-12-19
2026-03-13
Brief Summary
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PURPOSE: This clinical trial is studying an assessment tool in older patients with cancer.
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Detailed Description
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Primary
* Determine whether a geriatric assessment tool can predict toxicity to chemotherapy, defined as grade 3 or 4 toxicity, hospitalization, dose delay or reduction, or discontinuation of chemotherapy due to toxicity, in elderly patients with cancer.
Secondary
* Explore the longitudinal impact of cancer and chemotherapy treatment on geriatric assessment parameters.
OUTLINE: Patients undergo assessments of functional status using the Timed Up and Go Assessment (measures physical mobility) and Karnofsky Physician-Rated Performance Rating Scale; and cognition using the Blessed Orientation-Memory-Concentration Test. These assessments are performed by healthcare personnel. Body mass index and the percentage of unintentional weight loss and the number of falls in the past 6 months are also assessed.
Patients also complete the following self-administered questionnaires: Instrumental Activities of Daily Living (measures level of functioning and need for services); Activities of Daily Living (measures higher levels of physical functioning); Karnofsky Self-Reported Performance Rating Scale (related to survival and clinically significant illness); Physical Health Section of the Older American Resources and Services Questionnaire (measures comorbidity and the impact on daily activities); Hospital Anxiety and Depression Scale; Medical Outcomes Study (MOS) Social Activity Limitations Measure (measures the impact of cancer on patients' social functioning); and MOS Social Support Survey Emotional/Information and Tangible Subscales (measures perceived availability of social support).
Patients then begin planned chemotherapy.
After completion of chemotherapy (or a maximum of 12 months from study entry), patients undergo assessments and complete self-administered questionnaires as described above.
PROJECTED ACCRUAL: A total of 750 patients will be accrued for this study.
Conditions
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Study Design
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NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Geriatric Assessment Tool
questionnaire administration
Questionnaire administered prior to chemotherapy and within 30 days of completion of chemotherapy.
cognitive assessment
Cognitive assessment to be obtained prior to chemotherapy and within 30 days of completion of chemotherapy.
psychosocial assessment and care
Psychosocial assessment and care to be obtained prior to chemotherapy and within 30 days of completion of chemotherapy.
Interventions
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questionnaire administration
Questionnaire administered prior to chemotherapy and within 30 days of completion of chemotherapy.
cognitive assessment
Cognitive assessment to be obtained prior to chemotherapy and within 30 days of completion of chemotherapy.
psychosocial assessment and care
Psychosocial assessment and care to be obtained prior to chemotherapy and within 30 days of completion of chemotherapy.
Eligibility Criteria
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Inclusion Criteria
* Pathologically confirmed cancer
* Receiving chemotherapy for either adjuvant treatment or metastatic disease prior to beginning a new chemotherapy regimen
PATIENT CHARACTERISTICS:
* Must be able to understand English
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior enrollment in this trial
* No concurrent enrollment on a phase I clinical trial
65 Years
120 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Dale William, MD
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Locations
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Tower Cancer Research Foundation
Beverly Hills, California, United States
City of Hope Medical Center
Duarte, California, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
Orange, California, United States
Yale Cancer Center
New Haven, Connecticut, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Countries
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Other Identifiers
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CHNMC-06170
Identifier Type: -
Identifier Source: secondary_id
MSKCC-06034
Identifier Type: -
Identifier Source: secondary_id
CDR0000540332
Identifier Type: REGISTRY
Identifier Source: secondary_id
06170
Identifier Type: -
Identifier Source: org_study_id
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